Wednesday, May 7, 2008

ISO 9001 - Preparing for ISO 9001:2008

As our firm specializes in providing ISO 9001 consulting services, we try to keep up with the latest news regarding ISO 9001 and related industry-specific standards. One of the most notable developments recently is the proposed release of ISO 9001:2008, which is scheduled for later this year.

In June of 2007, ISO’s Technical Committee TC-176, which is the committee responsible for ISO 9001, concluded that the document was now sufficiently mature to move from a Committee Draft (CD) to the Draft International Standard (DIS) and Final Draft International Standard (FDIS) phases. Upon balloting by ISO members during these phases, the official publication would then be released as an International Standard (IS).

The DIS version of ISO 9001 was released in January of 2008, and out of the changes proposed, it appear that the majority of proposed changes are clarifications or additional examples relating to existing requirements, and should not have any major impact on an established system that was properly implemented.

An overview of the Clauses within ISO 9001 affected by these proposed changes includes:

• Clause 0.2 (Process approach)
• Clause 1.1 (Scope)
• Clause 4.1 (General requirements)
• Clause 4.2.1 (Documentation)
• Clause 4.2.3 (Document control)
• Clause 4.2.4 (Records control)
• Clause 5.5.2 (Management rep)
• Clause 6.2.1 (Human resources)
• Clause 6.3 (Infrastructure)
• Clause 6.4 (Work environment)
• Clause 7.2.1 (Customer related processes)
• Clause 7.3.1 (Design & development planning)
• Clause 7.3.3(Design & development outputs)
• Clause 7.5.4 (Customer property)
• Clause 7.6 (Control of Monitoring and Measuring Equipment)
• Clause 8.2.1 (Customer satisfaction)
• Clause 8.2.3 (Monitoring / Measurement of process)

As I mentioned earlier, it doesn’t appear that the majority of these changes would have a major impact on an established system. While minimal change is expected during the next comment period, the contents of the DIS are subject to change however.

As for ISO 9004, significant changes are expected, and as a result, 9004 will not be updated at the same time as ISO 9001. The proposed title of this revision is "Managing for sustainable success – a quality management approach." Until its revision, the 9004 standard will remain a companion document to ISO 9001.

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